Infertility Clinical Trial
Official title:
A Prospective, Non-inferiority Randomized Double-blinded Trial Comparing Fentanyl and Midazolam vs Diazepam and Pethidine for Pain Relief During Oocyte Retrieval
Verified date | February 2019 |
Source | Kwong Wah Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of the trial is to compare fentanyl and midazolam vs diazepam and pethidine in terms of the pain levels and post-operative side effects of TUGOR
Status | Completed |
Enrollment | 170 |
Est. completion date | February 2018 |
Est. primary completion date | February 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - presence of both ovaries; - body mass index less than 30 - written informed consent and - Chinese Exclusion Criteria: - IVF cycle converted from ovulation induction or intrauterine insemination cycles; - patient requests general anaesthesia for TUGOR; - history of drug sensitivity to lignocaine/fentanyl/midazolam/diazepam/pethidine; - less than 3 dominant follicles present; - dominant follicles present in one ovary only and - TUGOR performed on one side only. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Kwong Wah Hospital | Queen Mary Hospital, Hong Kong, The University of Hong Kong |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Level During Oocyte Retrieval | The pain level will be scored using visual analogue scale 0-10, 0 = no pain, 10 =most painful | will be assessed within 4 hours of oocyte retrieval | |
Primary | Pain Level After Oocyte Retrieval | The pain level will be scored using visual analogue scale 0-10, 0 = no pain, 10 =most painful | will be assessed within 4 hours of oocyte retrieval | |
Secondary | Percentage of Participants With Side Effects by Type | side effects will be scored by yes or no | will be assessed within 4 hours of oocyte retrieval | |
Secondary | Patient's Satisfaction on Oocyte Retrieval | satisfaction will be scored from 0-3 (0=excellent, 1=satisfactory, 2=fair, 3=unsatisfactory) | will be assessed within 4 hours of oocyte retrieval | |
Secondary | Clinical Pregnancy Rate | presence of intrauterine sac in ultrasound after a positive pregnancy test | will be assessed within ten weeks of oocyte retrieval | |
Secondary | Ongoing Pregnancy Rate | positive fetal heart pulsation seen in ultrasound at eight weeks of gestation | will be assessed within ten weeks of oocyte retrieval | |
Secondary | Patient's Satisfaction on Pain Relief | satisfaction on pain relief will be scored at 0-10 (10 being most satisfied) | within 4 hours after retrieval | |
Secondary | Sedation Level | S = sleeping, easily aroused; 1 = awake and alert; 2 = occasionally drowsy, easy to arouse; 3 = frequently drowsy, arousable, drifts off to sleep during conversation; 4 = somnolent, minimal or no response to stimuli | immediately after retrieval |
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